The Norwegian Medicines Agency takes over the responsibility for medical device in Norway

07 Jul The Norwegian Medicines Agency takes over the responsibility for medical device in Norway

Ministry of Health and Care Services has decided that The Norwegian Directorate of Health ‘s administrative tasks related to the area of medical equipment is to be transferred to The Norwegian Medicines Agency from 1 January 2018.

The technological developments on the site have gone very fast since the EEA regulations were adopted at the beginning of the 1990s. This is the background for a new regulatory framework for medical equipment that was adopted by the European Parliament 5 April 2017. The Ministry believes that it is natural to see a transfer of the field from the health services to the pharmaceutical plant in the context of the introduction of the new regulations. The Ministry has further emphasised that the area medical equipment located under the drug plants in Denmark and Sweden, and that the same is true in pretty much all other EU countries.